medical Class II Updated 2021-09-22

CAREFUSION recalls BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCE

Recalled Product

BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E

Hazard / Issue

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Lots: 20025450 20025451 20025452 20025531 20025532 20025533 20025534 20026527 20026529 20026532 20026533 20026534 20065580 20065582 20065581 20075239 20075240 20075241 20075242 20075618 20075619 20075447 20075448 20075449 20075450 20075451 20075452 20075453 20075790 20075791 20075924 20075792 20085362 20085363 20085364 20085365 20085421 20085422 20085522 20085523 20095302 20095303 20095310 20095533 20095534 20095311 20095312 20116500 20116501 21016470 21016471 21016593 20035697 20066252 20066399 20076260 20095373 20095887 20105859 20105860 20105861 20106710 21019903 21019904 21019905

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